Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit
2013 Archived Content

Fourth Annual | June 3 - 4, 2013
Mastering Clinical Trial Monitoring

The Premier Event for Experienced Clinical Trial Monitors

The fourth annual Mastering Clinical Trial Monitoring conference will focus exclusively on the changing, significant and growing expectations of clinical trial monitors. Thought leaders will share their experiences related to recent global regulatory agency activities, including the FDA’s new risk-based monitoring guidance, tools and techniques of monitoring best practices, monitoring in electronic environments and the challenges associated with monitoring international studies. Themes throughout the conference will be incorporating the latest regulatory requirements and expectations into your monitoring activities, and monitoring in unique environments, including device, IVD and investigator-initiated trials. The conference will feature case studies, hands-on activities, take-away tools, breakout groups and interactivity.

Day 1 | Day 2 | Download Brochure 

Monday, June 3, 2013

7:00am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks


8:15 Innovative Cross-Functional Approach to Monitoring: Using the Draft Guidance as a Roadmap to Improved Clinical Data Quality

Lynn King, Assistant Vice President, Operations, Rho

Targeted SDV and risk based monitoring is a topic of increased interest for many companies looking to decrease costs while maintaining quality, but there are few tools and limited information available for monitors on the “how tos” of using these strategies. Our changing approach of data monitoring in the industry requires the tools and team structure to effectively plan and successfully execute risk-based monitoring. Attendees will learn multi-disciplinary approaches to successfully implement alternative monitoring plans and specialized tools for successfully executing risk-based monitoring.

9:00 FDA Risk-Based Monitoring: Understanding the Impact on Daily Monitoring Activities

Ethel Kagan, President, Consulting, Innovations Clinical Research LLC

With risk-based monitoring, the FDA has essentially given industry permission to reduce onsite visits drastically. It is not yet clear how this, as well as the advent of EDC, will affect the traditional CRAs ability to find work. This presentation will provide experienced and novice CRAs with the tools to work effectively in this new environment; provide guidance to companies on how to best utilize monitors to ensure data integrity and patient safety, while still reaping the cost advantages of this novel approach; and demonstrate how study personnel working together as a team create monitoring plans that can stand up to FDA audits. It will provide CRAs with the tools they need to work in this new environment thus protecting their livelihood.

9:45 Networking Coffee Break and Exhibit Viewing


10:15 Real World Implementation of Risk-Based Monitoring and the Merging of Traditional Roles to Ensure Quality and Cost-Effectiveness

Candace Friend Shelton, Director, Clinical Monitoring Services, Celerion

This session will provide an example of a real-world successful implementation of risk based monitoring within Early Stage Development Phase I studies. Merging traditional silo operational roles is expected to improve efficiencies to ultimately reduce the time spent and overall monitoring cost. The new CRA-DM-Stats-QA-QC individual ensures the flow of data in real time to a centralized data group, reviews these data continuously, and should be able to immediately evaluate risk with the assistance of technology precluding routine site visits. Well-defined objectives are provided to be agile while allowing continual data evaluation, adjustment, and adjudication thereby producing clean, dependent data while following all local and ICH/GCP standards and ensuring the rights, safety, and well-being of the subjects.

11:00 Interactive Roundtable Discussions

11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


1:00pm Building Good Research Sites

Vickie Haines, RN, CRA, Senior Clinical Research Monitor, Sorin CRM USA, Inc.

Building quality research sites is a huge task. The painstaking time and money spent interviewing, verifying and qualifying a site is worth its weight in gold to a study’s outcome. A good site is comprised of several key elements and resources. Good, clean data will be received from good sites. How do we take a bad site and transform it into a gold standard site? We start with the basics: training, communication, more training, and retraining.

1:45 Creating and Managing a GCP Culture among Study Teams: Tools, Tips and Tricks

Shankar Srinivasan, Ph.D., CCRC (ACRP); Senior Regulatory Specialist, Office of Research Regulatory Support, Mayo Clinic

2:30 Site Relationship Management: Techniques for Site Selection, Proactive Management, Support, and Issue Escalation

Karen L. Gilbert, BS, CCRA, Clinical Trainer & Curriculum Manager, Barnett International

Elizabeth Wilson, CCRA, Manager, Clinical Operations, Covance, Inc. 

Managing site relationships is a critically important function of today’s clinical research monitor. Sometimes, however, little thought is given to that relationship until something goes wrong. This presentation will introduce techniques that build relationships of mutual trust and respect between site personnel and monitors. A single site relationship case study will be used throughout the presentation to demonstrate the application of the various techniques across time. Participants will learn to:

  • Set clear expectations during the site selection phase
  • Identify and minimize the impact of site weaknesses
  • Support quality improvement efforts at the site
  • Promptly manage site issues while preserving the relationship

Aris Global3:15 Investigator Selection & Site Monitoring - Eliminate Inefficiency and Reduce Costs

Simon Sparkes, Senior Vice President, Clinical & Compliance, ArisGlobal

Weaknesses in current investigator selection and monitoring approaches place an intolerable burden on sponsors and CROs. This session will focus on how companies can improve site selection and monitoring techniques, highlighting differences between risk and event-based monitoring while examining best practices in monitoring scheduling and visit conduct.

3:30 Networking Refreshment Break and Exhibit Viewing

3:50 Herding Cats: Identifying What Site Staff Need from You to Get the Job Done

Sarah Ramey, CRA, Clinical Operations, Duke Clinical Research Organization

Study Coordinators and Principal Investigators often (legitimately) feel they face challenges in complying with widely different/contradictory sponsor expectations. Monitors often (legitimately) feel they face challenges in teaching basic GCP principals. In this session, we will consider:

  • The whats and hows to securing compliance
  • Common archetypes of staff personalities
  • Tailoring negotiation, motivational, and/or corrective techniques to different personalities
  • The seasoned monitor’s Achilles’ Heel: delineating good clinical practice from “perfect clinical practice”

The presenter will draw on her experience of turning around three very different non-compliant sites in different therapeutic areas into compliance. Come ready to discuss your best negotiation, motivational, and corrective techniques.

4:35 The Two Are We: I Need You, and You Need Me. Navigating the Coordinator/Monitor Relationship

Kristen L. Bauer, CCRP, Senior Regional Clinical Research Associate, BIOTRONIK, Inc.

The relationship between a monitor and a coordinator can be fragile and difficult to navigate. Often times there are frustration and discord found on both sides, causing strain in the relationship. Common frustrations shared by monitors include sites being unprepared for visits, little to no oversight by the Investigator, lack of research policies or procedures, and no sense of urgency to bring study into compliance once issues are identified. Common frustrations shared by coordinators include last minute or rescheduled visits, frequent turn over in monitors, a lack of experience/training, and unreasonable action items. Ways to improve a strained coordinator/monitor relationship are to share expectations up front, communicate unique working situations, be flexible, and to share the common goal of wanting the data to be clean, and site to be as close to audit ready as possible.

5:20 Reception and Exhibit Viewing (Sponsorship Opportunity Available)

5:45 Short Course Registration

6:00 - 8:30 Dinner Short Course 1, Project Management of CROs 

6:20 Close of Day One

Day 1 | Day 2 | Download Brochure